MAUDE Adverse Event Report: WAISMED LTD. NIO ADULT; INTRAOSSEOUS ACCESS DEVICE FOR ADULTS

Model Number	NIO-A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2025
Type of Reportable Event	Death
Event or Problem Description
Patient was in cardiac arrest with cpr being performed.Crew arrived and took over cpr.Iv was attempted and failed.Nio was brought out, site located and when we spun the top on the nio to unlock it, it was tight to turn.Pressure placed with dominant hand, other hand stabilizing nio.Nio did not deploy, second crewmember attempted to deploy it and it did not work.Second nio was brought out and the same thing happened.Top was tight to spin and it did not deploy for either the rn or aemt.Manual io was placed in this patient first attempt.Cpr continued.Patient died.One of the nio that did not deploy was brought back to the station and is currently being sent back with the provided shipping label.

• Brand Name: NIO ADULT
• Common Device Name: INTRAOSSEOUS ACCESS DEVICE FOR ADULTS
• Manufacturer (Section D): WAISMED LTD.; 10 amal st.; afek industrail park; rosh ha'yin , israel, 48092 34; IS 4809234
• MDR Report Key: 21756448
• Report Number: 3008258694-2025-00001
• Device Sequence Number: 8220819
• Product Code: FMI
• UDI-Device Identifier: 07290008325059
• UDI-Public: 07290008325059
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2025
• Report Date (Section F): 04/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NIO-A
• Device Catalogue Number: NIO-A
• Device Lot Number: 2440043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/27/2025
• Date Report to Manufacturer: 04/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Date Report Sent to FDA: 04/02/2025